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【ChiCTR2300072788】Effects of a multicomponent intervention on functional ability in community-dwelling older people: a randomized controlled trial

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基本信息

登记号

ChiCTR2300072788

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2023-06-25

临床申请受理号

靶点

适应症

Functional ability

试验通俗题目

Effects of a multicomponent intervention on functional ability in community-dwelling older people: a randomized controlled trial

试验专业题目

Effects of a multicomponent intervention on functional ability in community-dwelling older people: a randomized controlled trial

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

To conduct a 12-week group-based multicomponent intervention for 300 persons aged 60 years or older to improve functional ability, and to promote healthy ageing.

试验分类

试验类型

随机平行对照

试验分期

其它

随机化

To obtain an adequate sample size, community centres under the eHealth project with the largest number of participants who have orare at risk of sarcopenia will be selected. Fifteen centres will be randomly selected and allocated to either group 1(receiving the multicomponent intervention without goal-setting), group 2 (receiving the multicomponent intervention with goal-setting), or group 3 (receiving the HLE program). We choose cluster RCT because randomization at the cluster (centre) level will reduce the likelihood of experimental contamination. Group 1 - receiving the multicomponent intervention without goal-setting. Group 2 - receiving the multicomponent intervention with goal-setting. Group 3 - receiving the HLE program.

盲法

Not stated

试验项目经费来源

The Hong Kong Jockey Club Charities Trust

试验范围

目标入组人数

100

实际入组人数

第一例入组时间

2023-07-01

试验终止时间

2024-06-30

是否属于一致性

入选标准

1. Community-dwelling older men or women aged 60 years and older; 2. Understand Cantonese; 3. With limited mobility without mobility disability (Short Physical Performance Battery score = 3-9); 4. Assessed with possible sarcopenia (low muscle strength (handgrip strength M: < 28 kg, F: < 18 kg) or low physical performance (5-chair rise test >= 12 s)); 5. Diagonised with sarcopenia (low appendicular skeletal muscle mass (bioelectrical impedance analysis M: < 7.0kg/m2, F: < 5.7kg/m2) and low muscle strength (handgrip strength M: < 28 kg, F: < 18 kg) and/or low physical performance (5-chair rise test >= 12 s)); 6. With history of falls in the past year; 7. With physical pre-frailty/frailty (FRAIL score >= 1); 8. With cognitive impairment (Montreal Cognitive Assessment 5-Minute Protocol Hong Kong Version score <= age and education corrected percentile cutoff, without doctor diagnosed dementia); 9. With impaired vitality (Mini Nutritional Assessment Short-Form score <= 11/low muscle strength (handgrip strength M: < 28 kg, F: < 18 kg).；

排除标准

1. Unable to get up from a chair (with or without using the armrests) and stand for 20 seconds; 2. Receive treatment for medical conditions that preclude physical activity; 3. Diagnosis of dementia, dementia suspected by a clinician, or terminal illness; 4. Interviewer-adjudicated severe visual or hearing impairment; 5. Participation in a structured physical activity program, nutritional activities or board game activities; 6. Contraindications to safely engage in trial activities as judged by health professionals (e.g., doctors, nurses, physiotherapists etc.).；

研究者信息

研究负责人姓名

试验机构

The Hong Kong Jockey Club Charities Trust

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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